Table 1.
Main clinical trials of stem cell therapy for liver cirrhosis.
| Trial number | Study phase (type) | Cell source | # | Eligibility criteria | Primary outcome measure | Secondary outcome measure | Time frame | Start date | End date | Location |
|---|---|---|---|---|---|---|---|---|---|---|
| NCT01875081 | Phase II (randomized open) | BM-MSC | 72 | Histologically or clinically diagnosed as alcoholic liver cirrhosis Classified as Child-Pugh grade B or C |
Histopathological evaluation | Histopathological evaluation score, MELD score, Child-Pugh grade, and so on | 6 months | 2012.11 | 2016.03 (completed) | Korea |
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| NCT02943889 | Phase I/II (nonrandomized open) | BM-MSC | 40 | Decompensated liver cirrhosis Child class b or c | Improvement of liver function in form of improvement in Child score | Postpone or overcome liver transplantation complications | 6, 24 months | 2016.10 | 2017.08 (not yet recruiting) | None |
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| NCT02786017 | Phase I/II (randomized double-blinded controlled) | UC-MSC | 40 | Subjects who are decompensated cirrhosis of any cause Child-pugh score ≥7 |
Change in the model for end-stage liver disease (MELD) score | Change in Child-Pugh score, clinical laboratory parameters of liver function | 1 and 3 days 1 and 2 weeks 1, 3, 6, 12, and 24 months |
2016.05 | 2018.12 (recruiting) | China |
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| NCT01591200 | Phase II (randomized open) | AlloMSC | 40 | Child class B or C, Child-Pugh scores of ≥7 and <14 MELD scores of at least 10 |
Safety | Liver function improvement, Child-Pugh score, MELD score, SF36-QOL, and so on | 24 months | 2012.06 | 2016.04 (completed) | India |
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| NCT01120925 | Phase I/II (randomized quadruple blind controlled) |
BM-MSC | 30 | MELD score of 12 or Child score B or C Serum ALT 1/5 times more than normal |
Liver function test | Cirrhosis mortality | 6 months | 2010.05 | 2013.07 (completed) | Iran |
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| NCT00420134 | Phase I/II (randomized single- blinded) |
MSC | 30 | MELD score of at least 10 Patent portal vein on color Doppler examination of the live Normal alpha-feto protein serum levels |
Liver function test MELD score |
Cirrhosis mortality | 6 months | 2006.02 | 2009.06 (completed) | Iran |
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| NCT01013194 | Phase I/II (nonrandomized open) | FLC | 25 | A score ≥ B8 based on the Child-Pugh-Turcotte classification and/or MELD score ≥ 14 | Survival | Analysis of Child-Pugh score, meld score from baseline to 1-year follow-up | 6 and 12 months | 2007.02 | 2011.07 (completed) | Italy |
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| NCT01342250 | Phase I/II (randomized open) | UC-MSC | 20 | Decompensated liver cirrhosis, Child-Pugh B/C (7–12 points) or Meld score ≦ 21. | Survival | Liver function improvement, Child-Pugh score, MELD score, SF36-QOL, and so on | 24 months | 2010.10 | 2011.10 (completed) | China |
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| NCT02652351 | Phase I (open) | UC-MSC | 20 | Clinical, radiological, or biochemical evidence of liver cirrhosis | Severity of adverse events | Hepatic function, liver fibrosis index | 1, 3, 6, and 12 months | 2016.03 | 2016.10 (recruiting) | China |
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| NCT01147380 | Phase I (nonrandomized open) | NK | 18 | Subjects who need to meet the liver transplant eligibility criteria Cardiac and pulmonary function |
Side effect of cadaveric donor liver NK cell infusion | NK cell infusion-related toxicity, anti-HCC, HCV effect | 12 and 24 months | 2010.06 | 2014.12 (completed) | USA |
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| NCT03254758 | Phase I/II (open) | AD-MSC | 15 | Chronic hepatitis C or nonalcoholic steatohepatitis (NASH) Child-Pugh grade B liver cirrhosis |
Child-Pugh score, safety profile | Child-Pugh score, safety profile | 6 months | 2017.07 | 2018.12 (recruiting) | Japan |
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| NCT01333228 | Phase I/II (open) | BM-EPC | 14 | Liver cirrhosis (Child-Pugh 8 or above) | Safety and tolerability | Effect on liver function, portal hypertension, complications of liver cirrhosis | 12 months | 2012.06 | 2015.03 (completed) | Spain |
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| NCT01503749 | Phase I (randomized open) |
PB-MNC (G-CSF) | 9 | Advanced liver cirrhosis with Child-Pugh score 8 or 9 | Severe adverse events | Change in Child-Pugh score and MELD score | 1–4 weeks 2–6 months |
2012.01 | 2014.08 (completed) | - |
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| NCT00713934 | Phase I/II (randomized single- blinded) |
BMMNC BMHSC |
7 | Liver biopsy showing histological cirrhosis, grade B or C (Child-Pugh score) liver cirrhosis in sonography study Liver crrhosis in sonography study |
Liver function test MELD score |
Cirrhosis mortality | 6 months | 2008.01 | 2009.02 (completed) | Iran |
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| NCT02297867 | Phase I (open) | ADSC | 6 | Investigators without HBV, HCV, HIV, syphilis, and so on | MELD | None | 1–6 months | 2015.07 | 2018.01 (active, not recruiting) | Taiwan |
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| NCT02705742 | Phase I/II (open) | AD-MSC | 5 | Clinical, radiologic, and pathologically proven liver cirrhosis due to HCV hepatitis | All cause mortality | - | 12 months | 2016.01 | 2017.12 (recruiting) | Turkey |
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| NCT01454336 | Phase I (open) | BM-MSC | 3 | Approved cirrhosis by elastography, biopsy, sonography | ALT, AST, serum albumin, liver fibrosis | Progression of fibrosis | 12 months | 2010.06 | 2013.07 (completed) | Iran |
#Number of enrollments; MELD, model for end-stage liver disease; UC-MSC, umbilical cord mesenchymal stem cell; AlloMSC, allogeneic MSC; FLC, fetal liver cell; BM-EPC, bone marrow-derived endothelial progenitor cells; PB-MNC, peripheral blood mononucleated cells; BMHSC, bone marrow CD133+ hematopoietic stem cell.